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Completed

NCT Number: NCT06266208

Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte

This study will evaluate the usefulness of ultrasonography in detecting dorsal osteophytes associated with claw nails compared to radiographs. The hypothesis will be that the larger the size of the osteophyte, the greater the nail curvature.

Nail curvature and osteophyte height will be measured in patients with clamp nails. Nail-phalange distance will also be measured with radiography and ultrasonography.

The investigators to find a positive correlation between nail curvature and osteophyte height. Furthermore, a strong agreement is expected between both imaging techniques to measure nail-phalange distance.

Ultrasonography could constitute a safe and effective alternative to radiology for detecting dorsal osteophytes in claw nails, especially in mild cases, follow-ups or young patients.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Enieto podologos, Logroño, La Rioja, Spain

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About this study

Main objective:

The investigators aim to explore the possible relationship between the degree of dorsal curvature of the nail plate and the height of the dorsal osteophyte in subungual exostosis patients before and after surgery.

Secondary objectives:

The investigators will compare the distance between the nail surface and the dorsal cortex of the distal phalanx using plain radiographs and high-resolution ultrasonography.

Materials and Methods:

This is an Interventional study patients experiencing nail pain due to clamp nails will be enrolled. Two groups will be formed depending on the presence of exostosis or not. Patients diagnosed with subungual exostosis who consent to surgery will undergo preoperative measurements. After surgery, these patients will be re-evaluated to assess the restoration of normal nail curvature values, as well as the height of the exostosis or its distance from the nail.

Measurements:

Nail curvature will be assessed using the nail curvature index, and nail height and thickness will also be measured. Dorsal osteophyte height will be assessed on radiographs and ultrasound images before and after treatment.

Expected results:

The investigators anticipate a positive correlation between dorsal osteophyte height and nail curvature. In addition, they do not expect significant differences in nail-phalange distance measurements between radiography and ultrasonography.

Conclusions:

High-resolution ultrasonography may emerge as an alternative diagnostic tool to detect subungual exostosis without exposure to ionizing radiation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical and radiological diagnosis of claw nail in at least one toe.
  • Pain associated with claw nail for at least 1 month.

Exclusion criteria

  • Pregnancy or breastfeeding
  • Previous trauma or surgery on the affected toe
  • Systemic diseases such as diabetes mellitus, renal insufficiency, rheumatoid arthritis
  • Current or previous treatment for ingrown toenail within the last year
  • Severe digital deformities (e.g. Hallux Valgus, hammer toe, claw toe)

Treatment and study plan

Exostectomy

Procedure

Patients diagnosed with dorsal osteophyte and experiencing pain were advised to proceed with osteophyte removal surgery during their initial visit.The surgical procedure, following protocol occurred during the second visit and involved the following steps: a 2-4 mm incision using a Beaver-64-MIS scalpel on the distal surface wall of the toe, parallel to its longitudinal axis, followed by careful osteophyte drilling; precise delineation of the osteophyte contour using a blunt elevator to prevent nailbed damage; resection executed through medial and lateral movements facilitated by a mini-Shannon drill; and finally, pressure application with a surgical spoon to extract the bone paste resulting from the drilling process.

Cut fingernail

Procedure

Patients diagnosed with dorsal osteophyte and experiencing pain underwent nail cut fingernail

Primary outcomes

  1. Nail-phalange distance

    Time frame: Pre-surgery, 2 months, 6 months.

    The measurement of the minimum distance between the dorsal cortex of the distal phalanx and the ventral aspect of the nail of the first toe will be done using lateral radiographs and longitudinal ultrasounds. Lateral radiographs capture toe images from a side angle to determine the spatial relationship between the two points, with measurements expressed in millimeters. Longitudinal ultrasounds provide real-time images to visualize this relationship, with the ultrasound transducer placed along the toe. Both methods offer vital insights into toe anatomy for medical purposes like assessing deformities, tracking injuries, or planning surgeries.

Secondary outcomes

  1. Nail Curvature Index

    Time frame: Pre-surgery, 1 months

    The maximum height and width of the nail plate in lateral view will be measured. The curvature index will be calculated as (nail height / nail width) x 100.

  2. Thickness of the nail plate

    Time frame: Pre-surgery, 1 months

    The maximum anteroposterior thickness of the nail plate in its medial part will be determined.

  3. Dorsal Osteophyte Height

    Time frame: Pre-surgery, 1 months

    The height of the subungual exostosis will be measured on lateral radiographs of the distal phalanx.

Sponsors and collaborators

Lead sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Other

Registry information

Official study title

Utility of High-resolution Ultrasound to Evaluate Dorsal Osteophyte Associated With Onychocryptosis: Correlation With Radiology.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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